Implant with a visual indicator of a barrier layer

Abstract

An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is the non-provisional of the provisional application No. 61 / 449,931, filed through the EFS with ID 9601953, on Mar. 7, 2011.BACKGROUND OF THE INVENTION[0002]This invention relates to an implantable prosthesis, comprising a multilayer molded elastomer shell, from which one or more of the layers are made of an elastomer with different chemical or physical properties, and which is afterwards filled with a liquid or a gel. Particularly, this invention relates to a prosthesis in which the differentiated layers are made visible by means of fabricating them with a different color material, so the differentiated layers can be easily identified in the final product by mere observation, providing a greater degree of safety of the device.[0003]Today, the augmentation and reconstruction of the human breast requiring the use of an implant, as well as the use of soft tissue implants in other parts of the human body, have become a fair...

AI Technical Summary

Benefits of technology

This patent is about a new type of implant that has a flexible layer made of elastomer. The elastomer layer contains a gel or liquid inside it. The innermost layer of the elastomer is in direct contact with the filler. The layers of the elastomer are made with a different material that will slow down the movement of the filling material particles through the implant. These layers have a different color to easily identify them. This design has several benefits. It allows for better visual identification of the barrier layer, ensures correct and consistent application, and simplifies quality control procedures. Medical professionals can easily verify the presence and correctness of the barrier layer by observing the color.

Problems solved by technology

Even though the performance of such barrier layers is considered acceptable at their present state of development, a serious problem persists in the use of this devices, both at the manufacturing and operating room levels, which is the impossibility for quality control personnel and medical staff of easily identifying the presence of the important low diffusion barrier layers within the complete prosthesis, without the use of impractical specialized equipment or without the use of destructive tests.

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